FDA approves biosimilar of J&J's Remicade drug to treat autoimmune diseases
Celltrion has secured approval from the US Food and Drug Administration (FDA) for its Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson's (J&J) Remicade drug used to treat autoimmune diseases.
Inflectra is indicated to treat patients with various severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
The FDA approval was based on the data package submitted by Celltrion which demonstrated a high degree of similarity between Inflectra and Remicade.
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